Cleared Traditional

MILES URINE CREATININE METHOD (K923039) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K923039 · Heraeus Kulzer, Inc. · Chemistry device
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Aug 1992
Decision
66d
Days
Class 2
Risk

K923039 is an FDA 510(k) clearance for the MILES URINE CREATININE METHOD. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Tarrytown, US). The FDA issued a Cleared decision on August 24, 1992 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K923039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1992
Decision Date August 24, 1992
Days to Decision 66 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 88d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGX Alkaline Picrate, Colorimetry, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CGX Alkaline Picrate, Colorimetry, Creatinine

All 54
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K923039.
CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2
K924599 · Em Diagnostic Systems, Inc. · Oct 1992
OLYMPUS CREATININE REAGENT
K923526 · Olympus Corp. · Sep 1992
SYSTEMATE CREATININE TEST
K923203 · Em Diagnostic Systems, Inc. · Sep 1992
SYNCHRON CREATININE TRIGGERED TEST CX4,5,7,
K915077 · Beckman Instruments, Inc. · Dec 1991
ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28
K913707 · Em Diagnostic Systems, Inc. · Sep 1991
SYSTEMATE CREATININE (EPOS APPLICATION) #65413
K905658 · Em Diagnostic Systems, Inc. · May 1991